Cleared Traditional

LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET

K973157 · Pointe Scientific, Inc., · Chemistry
Oct 1997
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K973157 is an FDA 510(k) clearance for the LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on October 10, 1997, 49 days after receiving the submission on August 22, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K973157 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1997
Decision Date October 10, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JQB — Kinetic Method, Gamma-glutamyl Transpeptidase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1360

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